Protocol Details
Elemental Diet for Treatment of Inflammatory Bowel Disease in Patients with Chronic Granulomatous Disease
This study is NOT currently recruiting participants.
Summary
Number |
19-I-0108 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 8 Years
Max Age: 65 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Pregnant Women |
Keywords |
Inflammatory Bowel Disease;
Crohn disease;
Ulcerative Colitis;
Glucocorticoids;
Microbiome |
Recruitment Keyword(s) |
None |
Condition(s) |
Chronic Granulomatous Disease;
Inflammatory Bowel Disease |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Other: Neocate Splash
|
Supporting Site |
National Institute of Allergy and Infectious Diseases |
Background:
Bacteria that live inside the stomach and intestines are important for health. Chronic granulomatous disease (CGD) and inflammatory bowel disease (IBD) can make people have unhealthy bacteria. This can lead to gastrointestinal (GI) problems. Researchers want to see if people with CGD and IBD feel better when they change the bacteria in the stomach by following a special liquid diet.
Objective:
To see if an elemental diet can change the bacteria in the stomach and intestines of people with CGD and IBD. Also, to see if this helps GI symptoms.
Eligibility:
People ages 8-65 years with CGD, CGD-associated colitis, and IBD.
Design:
Participants will first be screened with:
Upper GI endoscopy and/or colonoscopy. A long, thin tube with a tiny camera at the end will be passed into the participant s body through the mouth or anus. Tissue will be collected. Participants will be sedated for the procedure. They will be sedated using a special mask or small plastic tube placed in an arm vein using a needle.
Participants will be put on the special diet for up to 4 weeks. They will stay in the hospital for up to 2 weeks. They will have check-ups. They will have blood, urine, and stool samples collected. They will keep a symptom diary to record how they feel and any GI symptoms.
Participants will have 2 follow-up visits. The first will be right after they finish the diet. The second will be 4 weeks later. They will have blood, urine, and stool samples collected. They will learn about re-introducing other foods into their diet.
Eligibility
INCLUSION CRITERIA:
Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 8-65 years.
- Have confirmed diagnoses of CGD, CGD-associated colitis, and IBD.
- Have a Simple Endoscopic Score for Crohn Disease (SES-CD) > 3 and/or HBI >= 5.
- Able to provide informed consent.
- Willing to allow storage of biological samples for future research.
- Willing to allow genetic testing on biological samples.
- Willing to be admitted as inpatient for up to 2 weeks to initiate the elemental diet.
EXCLUSION CRITERIA:
- Pregnancy.
- Active or ongoing infection that requires antibiotics other than the participant s known prophylaxis medications.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.
Citations:
Jones LB, McGrogan P, Flood TJ, Gennery AR, Morton L, Thrasher A, Goldblatt D, Parker L, Cant AJ. Special article: chronic granulomatous disease in the United Kingdom and Ireland: a comprehensive national patient-based registry. Clin Exp Immunol. 2008 May;152(2):211-8. doi: 10.1111/j.1365-2249.2008.03644.x.
Magnani A, Brosselin P, Beaut(SqrRoot)(Copyright) J, de Vergnes N, Mouy R, Debr(SqrRoot)(Copyright) M, Suarez F, Hermine O, Lortholary O, Blanche S, Fischer A, Mahlaoui N. Inflammatory manifestations in a single-center cohort of patients with chronic granulomatous disease. J Allergy Clin Immunol. 2014 Sep;134(3):655-662.e8. doi: 10.1016/j.jaci.2014.04.014. Epub 2014 Jun 27.
van den Berg JM, van Koppen E, Ahlin A, Belohradsky BH, Bernatowska E, Corbeel L, Espa(SqrRoot) ol T, Fischer A, Kurenko-Deptuch M, Mouy R, Petropoulou T, Roesler J, Seger R, Stasia MJ, Valerius NH, Weening RS, Wolach B, Roos D, Kuijpers TW. Chronic granulomatous disease: the European experience. PLoS One. 2009;4(4):e5234. doi: 10.1371/journal.pone.0005234. Epub 2009 Apr 21.
Contacts:
Clinical Trials Number:
NCT03983837